Powering the Trial Despite Uncertain Event Rates

About our Guests: 

Fran Balamuth, MD, PhD, MSCE, is division chief of Pediatric Emergency Medicine at the Children’s Hospital of Philadelphia. Dr. Balamuth’s research interests focus on pediatric sepsis recognition using epidemiologic and translational approaches, for which she has received NIH and foundation funding. She is the co-PI of the PROMPT BOLUS trial, a multinational pragmatic trial comparing saline vs balanced fluids in pediatric sepsis, which will be the largest acute care pediatric trial in history. In addition, she co-leads the CHOP Pediatric Sepsis Program, which supports and promotes local clinical, research, educational, and quality-improvement initiatives related to sepsis. She is an internationally recognized sepsis leader, and has been invited to serve on the national steering committee for the Improving Pediatric Sepsis Outcomes quality collaborative through the US Children’s Hospital Association, and 2 international task forces focused on defining pediatric sepsis through the US Centers for Disease Control and Prevention and the Society of Critical Care Medicine.

Scott L. Weiss, MD, MSCE, FCCM, is a Professor of Pediatrics & Pathology and Genomic Medicine at Thomas Jefferson University and division chief of Critical Care Medicine at Nemours Children’s Hospital, Delaware. Previously, Dr. Weiss was on the faculty at the Children’s Hospital of Philadelphia, where he earned recognition as an international expert in pediatric sepsis. Dr. Weiss’ NIH-funded research focuses on epidemiology, fluid resuscitation, and mitochondrial dysfunction in pediatric sepsis. Dr. Weiss is an international expert in pediatric sepsis and served as the co-PI of the PRoMPT BOLUS trial.

Nathan Kuppermann, MD, MPH, is Executive Vice President and Chief Academic Officer of Children's National Hospital and Director of the Children's National Research Institute. He also serves as chair of the Department of Pediatrics and associate dean of Pediatric Academic Affairs at the George Washington University School of Medicine and Health Sciences. He is an internationally recognized clinical trialist in pediatric trauma, pediatric DKA, and acute pediatric infections. As the original chair of the Pediatric Emergency Medicine Applied Research Network (PECARN); his research is focused on clinical trials and clinical prediction rules using large cohorts of acutely ill and injured children. Dr. Kuppermann served as the senior investigator of the PRoMPT BOLUS trial.

Selected References:

1. Weiss SL, Balamuth F, Long E, Thompson GC, Hayes KL, Katcoff H, Cook M, Tsemberis E, Hickey CP, Williams A, Williamson-Urquhart S, Borland ML, Dalziel SR, Gelbart B, Freedman SB, Babl FE, Huang J, Kuppermann N; Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial. Trials. 2021 Nov 6;22(1):776. doi: 10.1186/s13063-021-05717-4. Erratum in: Trials. 2025 Oct 7;26(1):390. doi: 10.1186/s13063-025-09164-3. PMID: 34742327; PMCID: PMC8572061.
2. Weiss SL, Balamuth F, Thurm CW, Downes KJ, Fitzgerald JC, Laskin BL. Major Adverse Kidney Events in Pediatric Sepsis. Clin J Am Soc Nephrol. 2019 May 7;14(5):664-672. doi: 10.2215/CJN.12201018. Epub 2019 Apr 18. PMID: 31000518; PMCID: PMC6500940.
3. Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27. PMID: 29485925; PMCID: PMC5846085.

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